Status:
COMPLETED
Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
Brief Summary
Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-...
Detailed Description
The present study is an explorative, observational study, which will include in total 60 participants divided over 3 groups; healthy young adults, healthy older adults and patients with a stable abdom...
Eligibility Criteria
Inclusion
- Young healthy group: Male or female between the age of 18 and 40 years old;
- Older healthy group: Male or female, which are age-/sex-matched with the AAA patients group;
- AAA patients group: Male or female with an abdominal aortic aneurysm who is still under surveillance, with a diameter between 3.0 and 5.0 cm and at least 18 years old. These patients may participate in the 1-2-3 Trial, which is a similar approved investigation by CMO region Arnhem-Nijmegen with registration number 2019-5216.
- Informed consent form understood and signed;
Exclusion
- Psychiatric or other conditions that may interfere with the study;
- Participating in another clinical study, interfering on outcomes;
- With regard to the necessary quality of the ultrasound images, BMI ≥ 30 kg/m2;
- Increased risk for coronary spasms (score Rose-questionnaire ≥2; this questionnaire can be found in the Appendix);
- Known carotid artery disease
- Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and/or scleroderma associated with placing the hand in ice water;
- Recent (\<3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and/or heart failure, or PAD treatment.
- Healthy groups:
- Systolic blood pressure \>140 and/or diastolic blood pressure \>90
- Cardiovascular history
- Antihypertensive medication
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04035252
Start Date
October 1 2019
End Date
October 5 2020
Last Update
October 12 2020
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
2
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA